Skid Conductivity Sensor (CAL-0313) – Calibration Documents

Calibration Documents: Skid Conductivity Sensor (CAL-0313)

Asset ID CAL-0313
Equipment Skid Conductivity Sensor
Equipment Type Conductivity Sensor
Department Biologics
Area/Location Downstream
Process Use Conductivity
Parameter Conductivity
Units mS/cm
Range Min 0
Range Max 200
Acceptance Criteria ±1%
Calibration Frequency (days) 180
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Skid Conductivity Sensor is performed to ensure accurate measurement of conductivity within the specified range. This calibration controls risks associated with data integrity, patient safety, and batch quality by ensuring that the sensor operates within defined tolerances, thereby maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0313
  • Equipment Name/Type: Skid Conductivity Sensor / Conductivity Sensor
  • Department/Area: Biologics / Downstream
  • Process Use: Conductivity
  • Parameter: Conductivity
  • Range: 0 to 200 mS/cm
  • Units: mS/cm
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement device to a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement device meets specified requirements.
  • Adjustment: The act of modifying a measurement device to bring it within specified limits.
  • As Found: The condition of the measurement device prior to any adjustments.
  • As Left: The condition of the measurement device after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement device does not meet specified acceptance criteria.
  • Drift: The gradual change in a measurement device’s output over time.
  • Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is asserted to lie.
  • Intermediate Check: A verification process conducted between calibrations to ensure ongoing accuracy.

4. References

  • Company Metrology SOP [TBD]
  • ISO/IEC 17025 traceability via calibration certificates
  • ALCOA+ principles

5. Responsibilities

  • Technician/Metrology: Perform calibration and maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure equipment is available and accessible for calibration.
  • External Service Provider: Conduct calibration as per external calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the sensor as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the sensor installation.
  • Verify power supply stability and functionality.
See also  Autoclave Timer (CAL-0152) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

The calibration will follow an As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints and midpoints across the range of 0 to 200 mS/cm.
  • Replicate readings at each point: 3 repeats to ensure accuracy unless otherwise specified.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the sensor to stabilize as per manufacturer recommendations.
  3. As Found checks and data capture: Record initial readings at specified points.
  4. Adjustment rules: If OOT is detected, adjust the sensor if allowed; otherwise, escalate to QA.
  5. As Left verification: Confirm that the sensor is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1%

Error calculation formula: Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If the error is within ±1%, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with company policy.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Points Reference Observed Error Acceptance Pass/Fail As Found As Left
[TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Annexure B: Quick Checklist

  • Check environmental controls.
  • Verify equipment cleanliness.
  • Ensure proper stabilization time.
  • Confirm power supply integrity.

Annexure C: Example Label Text

Calibration Date: [TBD]

See also  Laminar Airflow Velocity (CAL-0170) - Calibration Documents

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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Calibration Protocol

Calibration Protocol

Protocol ID Asset ID Equipment Name Equipment Type Dept Area Process Use Parameter Units Range Acceptance Criteria Frequency Calibration Type Traceability
[TBD] CAL-0313 Skid Conductivity Sensor Conductivity Sensor Biologics Downstream Conductivity Conductivity mS/cm 0 – 200 ±1% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Minimum: 0 mS/cm
  • 25% of Range: 50 mS/cm
  • 50% of Range: 100 mS/cm
  • 75% of Range: 150 mS/cm
  • Maximum: 200 mS/cm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 mS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
100 mS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
150 mS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
200 mS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Skid Conductivity Sensor is clean and calibrated within the last 180 days.
  2. Stabilization: Allow the sensor to stabilize for [TBD] minutes before taking readings.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error as: Error = (Observed – Ref Value) / Ref Value * 100%
  5. Evaluation: Compare the error against the acceptance criteria of ±1%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • Open a deviation report.
  • Quarantine impacted results window: [TBD]
  • Await QA decision on further actions.

Approvals

Prepared Reviewed Approved
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0313 Skid Conductivity Sensor Biologics Downstream Conductivity 0 – 200 mS/cm ±1% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow sensor to warm up as per manufacturer instructions
  • [ ] Clean the sensor according to SOP
  • [ ] Ensure the sensor is leveled properly
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for entries
See also  UV-Vis Spectrophotometer (CAL-0110) - Calibration Documents

As Found Execution

  • [ ] Set the sensor to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the sensor
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm results are within acceptance limits

Documentation & Closure

  • [ ] Update equipment label
  • [ ] Attach calibration certificate
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

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Deviation Impact Assessment

Event Summary
Asset: Skid Conductivity Sensor
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the asset
  • Label/tag the asset as out of tolerance
  • Segregate impacted work

Define Impact Window

Last known in-tolerance date: [TBD] to discovery date: [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID Results Potentially Impacted Re-test/Re-weigh Decision
[TBD] [TBD] [TBD]

Data Integrity Review Prompts (ALCOA+)

  • Attributable: [TBD]
  • Legible: [TBD]
  • Contemporaneous: [TBD]
  • Original: [TBD]
  • Accurate: [TBD]
  • Complete: [TBD]
  • Consistent: [TBD]
  • Enduring: [TBD]
  • Available: [TBD]

Risk Assessment

Severity Probability Detectability Rationale Overall Risk
[TBD] [TBD] [TBD] [TBD] [TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID Equipment Name Equipment Type Dept Area Make/Model Serial No Location Parameter/Range/Units Acceptance Criteria
CAL-0313 Skid Conductivity Sensor Conductivity Sensor Biologics Downstream [TBD] [TBD] [TBD] Conductivity (0 – 200 mS/cm) ±1%

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Measured Value (mS/cm) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (mS/cm) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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